In February 2023, the Medical Device Coordination Group (MDCG) published a new revision of the Guidance on classification rules for IVD medical devices. The revision of this MDCG document from 2020 includes some minors changes and one addition. In particular, the updated MDCG Guidance has a new Annex (Annex II), which provides a flowchart to help determine whether an IVD is a companion diagnostic (CDx).
Flowchart to help determine whether an IVD is a CDx
As defined . . .
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